Enhanced Pre-Wetted Intermittent Catheter with Lubricious Coating

ABSTRACT

The present disclosure relates to a packaged urinary catheter. The catheter includes a conduit having a proximal end and a distal end. The distal end includes at least one aperture for receiving urine from the bladder. The catheter is contained within a sleeve having a length, a width, and a size configured to receive the catheter. According to one embodiment, the catheter and the sleeve may be arranged in a helical coil. The outer surface of the catheter may have a lubricious and/or an antimicrobial coating.

Intermittent catheters are generally catheters or tubes having a roundedtip connected to a distal end that is inserted into the bladder of apatient or user, and a molded funnel connected to a proximal end thatremains outside the body of the patient or user. These types ofcatheters are typically utilized on a temporary basis to remove urinefrom the bladder of a patient or user. The distal tip may include slotsor openings on the shaft to facilitate drainage of urine therefrom oncethe tip is positioned inside the bladder. Pre-wetted intermittentcatheters are intermittent catheters having a highly lubricious coatingon an outer surface thereof, which are packaged or otherwise broughtinto contact with fluid in order to provide a catheter with a slipperyouter surface to facilitate insertion into the patient or user.

Intermittent catheters are well-known in the art, and include thosedisclosed in U.S. Pat. Nos. 5,895,374; 6,059,107; 6,634,498; 7,311,698;6,849,070, 7,615,045; 6,736,805; 7,087,048; 7,380,658; and 6,355,004,the disclosures of which are all incorporated herein by reference intheir entirety as if fully set forth herein.

The current offerings of pre-wetted intermittent catheters can be brokenup into three broad categories. In the first type, the catheter ispackaged in a dry environment, but contains a lubricious coating thatrequires a wetting fluid in order to become hydrated. The wetting fluidis obtained from an external source by the user (e.g., sink, bottledwater, etc.) and the catheter is positioned within the wetting fluid fora period of time to become hydrated. Use of this first type ofintermittent catheter may prove difficult in the event that drainagemust be performed by the user when no clean water or wetting fluid isavailable. Moreover, sterility of the catheter may be compromised due tothe handling of the catheter by the user as wetting fluid is applied andthereafter during insertion.

A second type of pre-wetted intermittent catheter is also packaged in adry environment and contains a lubricious coating. In this second type,the wetting fluid is positioned in a pouch or container within thecatheter package itself such that to hydrate the catheter, the pouch orcontainer must be opened when the user is ready for insertion. A thirdtype of pre-wetted intermittent catheter is packaged in a wetenvironment (i.e., the catheter is exposed to a wetting fluid within thecatheter package).

Intermittent catheterization is generally performed a minimum of threetimes a day by the patient or a care giver in order to drain thebladder. The genital area near the urethral opening is wiped with anantiseptic agent, such as iodine. A lubricant may then be used tofacilitate the entry of the catheter into the urethra. A topical localanesthetic may also be applied to numb the urethral opening during theprocedure. The catheter packaging is opened, and the catheter isremoved. One end of the catheter is placed in a container, and the otherend is inserted into and guided up the urethra and into the bladderuntil urine flow begins.

Some patients requiring intermittent catheterization may have limiteddexterity resulting from, for example, traumatic brain or spinal cordinjury, or a disease state (e.g., spina bifida, multiple sclerosis).Such patients may have difficulty opening the packaging of anintermittent catheter, and may further have difficulty during insertion.Fumbling with the catheter and/or its packaging is potentially harmfulto the patient, because the sterile surfaces of the catheter may becomenon-sterile. Inserting a non-sterile urinary catheter increases thelikelihood of contracting a urinary tract infection.

Packaging is a separate issue associated with intermittent urinarycatheterization. It could be desirable to provide an intermittenturinary catheter in a discrete, compact packaged unit to improve theease of use, convenience, and privacy of the intermittentcatheterization process for the user.

Thus, there is a need for an intermittent catheter that addresses atleast one of the needs of the patient or user, e.g., is easy to use, isquick, clean, compact, capable of use with or without a bag, and iscapable of maintaining sterility during insertion procedures.

BRIEF SUMMARY OF THE INVENTION

Accordingly, a packaged urinary catheter is described herein, comprisinga conduit having a proximal end and a distal end, wherein the distal endcomprises at least one aperture for receiving urine from the bladder; asleeve having a length, a width, and a size configured to receive theconduit, wherein the sleeve surrounds substantially the entire length ofthe conduit; and wherein the conduit and the sleeve are arranged in ahelical coil.

In one embodiment, the shape of the helical coil is maintained byportions of the sleeve being releasably fixed together along at least aportion of the length of the sleeve.

In another embodiment, a first cap seals a proximal end of the sleeve,and a second cap seals a distal end of the sleeve.

In another embodiment, at least one of the first and second capscomprises a gripping feature configured to be grasped by a patient oruser of the packaged urinary catheter.

In another embodiment, the gripping feature is sized and shaped toreceive a finger therethrough.

In another embodiment, portions of the sleeve are releasably fixedtogether by a perforated section along a length of the sleeve.

In another embodiment, the packaged urinary catheter is released fromthe helical coil configuration by grasping the first and second caps,and urging the caps in substantially different directions.

In one embodiment, a lubricating material is contained within thesleeve.

In another embodiment, the lubricating material is chosen from water, ahydrogel, and a vapor.

In another embodiment, at least a portion of the outer surface of theconduit is hydrophilic.

In another embodiment, there is disclosed a synthetic polyisopreneconduit having a proximal end and a distal end, wherein the distal endcomprises at least one aperture for receiving urine from the bladder; asleeve having a length, and a width, and a size configured to receivethe conduit, wherein the sleeve surrounds substantially the entirelength of the conduit; and wherein the conduit and the sleeve arearranged in a helical coil.

These and other embodiments, methods, features and advantages willbecome more apparent to those skilled in the art when taken withreference to the following more detailed description of the invention inconjunction with the accompanying drawings that are first brieflydescribed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of an intermittent catheter accordingto the present disclosure.

FIG. 2 illustrates one embodiment of an intermittent catheter inaccordance with the present disclosure, with the end caps removed.

FIG. 3 illustrates a cutaway view of one embodiment of an intermittentcatheter in accordance with the present disclosure.

FIG. 4 illustrates a side view of one embodiment of an intermittentcatheter in accordance with the present disclosure.

FIG. 5 illustrates one embodiment of an intermittent catheter inaccordance with the present disclosure.

FIG. 6 illustrates an intermittent catheter in a partially deployedconfiguration, in accordance with one aspect of the present disclosure.

FIG. 7A illustrates the proximal end of an intermittent catheter in aurine disposal bag, in accordance with one aspect of the presentdisclosure.

FIG. 7B illustrates a sealing washer at the distal end of a cathetersleeve, in accordance with one aspect of the present disclosure.

DESCRIPTION OF THE INVENTION

The following description should be read with reference to the drawings,in which like elements in different drawings are identically numbered.The drawings, which are not necessarily to scale, depict selectedembodiments and are not intended to limit the scope of the invention.The detailed description illustrates by way of example, not by way oflimitation, the principles of the invention. This description willclearly enable one skilled in the art to make and use the invention, anddescribes several embodiments, adaptations, variations, alternatives anduses of the invention, including what is presently believed to be thebest mode of carrying out the invention.

As used herein, the reference terms “proximal” and “distal” (proximalbeing closer than distal) refer to the proximity with respect to ahealth care professional or other person other than a patient that isassisting the patient in using the catheter apparatus. In the case thata user is implementing the catheter apparatus without the aid ofanother, “proximal” and “distal” refer to the proximity with respect toa point external to the user's body. Thus, for example, a region orsection of the catheter apparatus that is close to a health careprofessional or the user's hand when the catheter apparatus is beingutilized is referred to as “proximal,” while a region or section of thecatheter apparatus distanced from a health care professional or theuser's hand when the catheter apparatus being used is referred to as“distal.”

The packaged catheter, as described herein, is discussed in the contextof a urinary catheter for insertion into a user/patient bladder fordrainage of urine therefrom. However, it should be appreciated that thepackaged catheter described could also be used for other applicationsnot specifically mentioned herein, and therefore should not be limitedto a urinary catheter application.

Generally, the packaged catheter includes a conduit, such as a catheteror tube, positioned within a sleeve. The conduit may have a roundcross-sectional shape, an oval cross-sectional shape, or any othercross-sectional shape that may facilitate insertion into a user's body,and in particular into a user's bladder through the urethra. Theconduit, in accordance with various embodiments, contains a lubriciousand/or antimicrobial coating on at least an outer surface thereof. Thelubricious coating can include a hydrogel or any coating that rendersthe surface of the conduit hydrophilic. Suitable non-limiting examplesof such coatings that may be used on the catheters disclosed herein maybe found in U.S. Pat. Nos. 6,329,488; 6,716,895; and 6,949,598; U.S.Patent Application Publication No. US 2004/0116551; and U.S. patentapplication Ser. No. 13/383,535, filed Jan. 11, 2012, which is aNational Phase application of International Application No.PCT/US2011/62086, titled “Deposition of a Silver Layer on aNon-Conducting Substrate,” and published as WO 2012/071536. Each of theabove-listed patents, publications, and applications is incorporated byreference into this application as if fully set forth herein.

Referring now to FIGS. 1-2, one embodiment of a packaged urinarycatheter 10 is shown, including a conduit 16 disposed within a flexiblesleeve 20. Conduit 16 has a proximal end 14, a distal end 12, an eyelet18 to receive urine, and a funnel 26 to dispense urine. The connectionbetween the conduit 16 and the funnel 26 can be accomplished by anymethod known to bond such materials together, for example by molding andor chemically bonding (with, e.g., cyclohexanone). Sleeve 20 has alength, a width, and a size configured to receive the conduit 16, andthe sleeve surrounds substantially the entire length of the conduit 16.

According to certain embodiments, the sleeve 20 is made of a gasimpermeable material, such as a polymer, for example polypropylene orpolyethylene. According to one embodiment, sleeve 20 is made of anon-rigid material, such as, for example, a foil material or the like,or films, such as polymeric films, for example polypropylene andpolyethylene films. The sleeve may be constructed from two blanks ofmaterial that are joined at the edges to form the sleeve. The edges ofthe blanks may be joined by typical methods known to those of ordinaryskill in the art, including heat, sonic, chemical, or physical bonding.

According to one embodiment, the sleeve 20 is configured to collapseupon itself to facilitate introduction of the conduit by a user and toprevent direct contact by the user with the conduit. The sleeve 20 mayinclude an introduction member (not shown) at the proximal end thereofto facilitate introduction of the conduit to facilitate disposal of thedrained urine. A suitable non-limiting example of an introducer isdisclosed in U.S. Pat. No. 4,692,154 (the disclosure of which isincorporated herein by reference in its entirety).

According to various embodiments, the sleeve contains within it awetting fluid. The purpose of the wetting fluid is to maintain hydrationof a lubricious coating on the conduit 16 such that upon insertion ofthe conduit into a user, at least an outer portion thereof is extremelyslippery, facilitating insertion.

The packaged catheter 10 includes first cap 24 for covering the proximalend 14 of conduit 16, and a second cap 22 for covering distal end 12 ofconduit 16. The distal cap 22 has a lumen 36 (FIG. 2) configured toreceive the distal tip of conduit 16. According to one embodiment, thelumen 36 receives both the distal tip of the conduit 16 and the distalend of the sleeve 20. According to another embodiment, the distal end ofthe sleeve is releasably joined to the proximal end of cap 22. Accordingto yet another embodiment, the inside diameter of sleeve 20 is joined tothe outside diameter of lumen 36.

Similarly, proximal cap 24 has a lumen 38 configured to receive thefunnel 26 of conduit 16. According to one embodiment, the lumen 38receives both the funnel and the proximal end of the sleeve 20.According to another embodiment, the proximal end of the sleeve 20 isreleasably joined to the distal end of cap 24. According to yet anotherembodiment, the inside diameter of lumen 38 is releasably joined to theoutside diameter of 20.

Patients who self-catheterize may have limited dexterity. Accordingly,it could be advantageous to provide caps 22 and 24 with graspingfeatures to facilitate removal by those of limited dexterity. Accordingto certain embodiments, caps 22 and 24 may have apertures 26 and 30,respectively, sized and shaped to receive at least one finger. Othergrasping features known to those of ordinary skill in the art are alsowithin the scope of the present disclosure.

According to certain embodiments, the sleeve 20 may have a tubular outersurface with a plurality of pre-formed pleats or folds (not shown) alonga middle portion thereof between a proximal end section 32 and a distalend section 34 of packaged catheter 10. The pleats or folds in the outersurface of the sleeve 20 permit the sleeve to compress or collapse uponitself in accordion-like fashion. According to another embodiment, thesleeve 20 does not contain pre-formed pleats or folds, but instead iscomprised of a thin, substantially flat, collapsible material.

The packaged catheter according to the present disclosure is designed toprovide a compact configuration for discreet transport and usage. Thismay be accomplished by providing the catheter in a folded or coiledconfiguration. The present disclosure contemplates helical coils, aswell as flat coils, or coils having any other configuration suitable forpackaging. Such a configuration may allow a user to stow a sufficientnumber of catheters in a backpack, purse, or pocket while preserving theuser's privacy and dignity.

FIGS. 1-2 show a packaged urinary catheter in a coiled configuration.According to one embodiment, the “coils” of the packaged catheter areheld together at joined edges 28 of the sleeve 20. The joined edges 28can be held together by a perforation in the sleeve 20, or by anyconventional bonding method known to those of ordinary skill in the art.The packaged catheter 10 is shown in cross-section in FIG. 3. A sideview of the packaged catheter 10 is shown in FIG. 4.

Cap 24 is configured for removal from the distal end 14 of the packagedcatheter, and urine is permitted to drain from funnel 26. In oneembodiment, the drainage funnel 26 of the conduit 16 is configured suchthat it can be inserted into, or otherwise connected to, a bag 40 (FIG.7) and sealed (or at least partially sealed) thereto such that fluidcommunication between the funnel 26 and the bag is established and aclosed system is provided to prevent exposure to contaminants to theuser or assistant (nurse, family member, etc.). Drainage of a user'sbladder can then take place directly into the bag 40, which cansubsequently be detached from the funnel 26 and either emptied andsanitized, or disposed of, in the case that the bag is made of adisposable material.

In one embodiment the bag includes an extension member (not shown)extending from an opening therein that both connects to the funnel 26and is shaped to receive the cap 24. According to another embodiment,the bag has a closure member 42 at the distal end thereof, allowing thebag to be closed once the catheterization process is completed.According to another embodiment, the bag 40 is sized and shaped to holda volume of urine and the used catheter and sleeve. According to yetanother embodiment, the bag 40 is packaged together with the catheter.For example, the bag can be provided in a folded configuration in thecenter 3 of the coiled catheter (FIG. 1), thus minimizing the totalspace occupied by the packaged catheter 10.

According to one embodiment, and as exemplified in FIG. 7B, a slidingseal member 42, such as a compressible washer, is incorporated into thedistal end sleeve 20, through which the conduit 16 is slidablypositioned, to permit sliding of the conduit 16 with respect to thesleeve 20. The seal formed between sleeve 20 and sliding seal member 42,and between sliding seal member 42 and conduit 16, may serve a number ofpurposes. For example, the seals may help to minimize exposure of theouter surface of the conduit 16 to the environment, thus minimizing aninfection risk. In addition, the seals may prevent loss or leakage ofthe wetting fluid from the volume formed between the inside surface ofsleeve 20 and the outside surface of conduit 16. The inside diameter ofthe end of sleeve 20 may be bonded to the outside diameter of the sealmember 42.

The catheter may have a round or substantially round cross-sectionalshape, an oval cross-sectional shape, or any other cross-sectional shapethat may facilitate insertion into the body of a user/patient, and inparticular, into the bladder of the user/patient through the urethra.According to various embodiments, the shape of the catheter can also bevariable along its length.

Different lengths, sizes (e.g., diameter, width, etc.), andconfigurations are possible for the conduit 16, depending on the user'sanatomy. For female users, the insertable length may range from 40 to100 mm, for example 50 to 80 mm, such as 55 to 75 mm. For male users,the insertable length can range from 100 to 300 mm, such as 190 to 240mm, for example 230 mm. For example, in one embodiment for an adult malehuman, the length of the conduit 16 may be in the range of about 8 toabout 18 cm and have an elliptical cross-sectional shape similar to theshape of the male urethra.

The proximal end of the conduit 16 includes a tip having a roundedatraumatic shape (e.g., bullet shape, etc.) and at least one opening 18or “eyes” in the sides of the tip that connect with a central conduitlumen such that placement of the conduit tip into a urine pool in thebladder results in drainage of urine therefrom. The tip design can varyaccording to the needs of a user, for example, the catheters disclosedherein can be provided with a coude tip.

As mentioned above, at least a portion of the outer surface of theconduit 16 is coated with a lubricious coating, which when contacted bya wetting fluid, becomes hydrated. The hydration of the lubriciouscoating results in a surface with a low coefficient of friction suchthat the conduit 16 is easily slidable into the body of a user. Thelubricious coating is made from a material such as those described inU.S. Pat. No. 6,329,488 or 4,642,267, the disclosures of which areincorporated herein by reference in their entirety.

One of the advantages associated with the packaged catheter of thepresent disclosure is ease of use. From the coiled configuration, a usercan grab each of caps 22 and 24, optionally through apertures 26 and 30,and urge the caps in substantially opposing directions shown by arrows Aand B (FIG. 5). The resulting force will uncoil the packaged catheter byallowing the edges 28 of the sleeve 20 to separate (FIG. 6). Once thecoils are sufficiently separated, the user can begin the catheterizationprocess. Cap 22 can be secured to the distal end of the conduit 16 orsleeve 20 by friction fit, threaded engagement (i.e., either the cap orthe distal end section contains threads, protrusions, etc. while theother contains grooves, detents, recesses, etc. to receive the threads,protrusions, etc.), or other like securing methods known to one skilledin the art. Once cap 22 is removed, the distal end of conduit 16 isinserted into the urethral meatus. According to one embodiment, theconduit is inserted in a way that avoids the user directly touching thesurface of the conduit (in order to minimize dragging harmful bacteriainto the user's urinary tract). This can be done by manipulating theconduit 16 only through sleeve 20.

Referring now to the device as illustrated in FIGS. 1-7, the packagedcatheter 10 as shown in FIG. 1 is coiled. The conduit 16, beingcontained completely within the sleeve 20 and surrounded by wettingfluid, is in a sterile condition and remains that way due to caps 22 and24. Cap 24 is removed, and the bag 40, which may be separately packagedor packaged along with the catheter apparatus 10, is connected to thefunnel 26 extending from the distal end of the catheter apparatus 10 asshown in FIG. 7A (in alternate embodiments not employing a bag, thisstep is not performed). According to another embodiment, the packagedcatheter has a bag 40 that surrounds cap 24, such that cap 24 isdisconnected by manipulating the cap through the bag.

Once the bag 40 has been connected to the catheter apparatus 10 and theuser is ready for insertion, the cap 22 is removed from the distal end12 of the conduit 16, and the conduit tip is placed into the user. Theuser or assistant then holds the catheter apparatus 10 at a distal end(e.g., the user grasps the funnel 26 with one hand, and the sleeve 20 orwasher 42 with the other hand) and pushes in a distal direction toextend the conduit 16 into the user and eventually into the user'sbladder, while simultaneously collapsing the sleeve 20 onto itself. Thisaction minimizes or eliminates exposure of the conduit 16 to conditionsor contaminants outside of the container. Drainage of urine from theuser's bladder then takes place and following evacuation, the proximalend of the catheter apparatus 10 is pulled in a proximal direction,while the distal end of the sleeve 20 (or the sealing member 42) is heldin place. This action results in the conduit 16 returning fully insidethe sleeve 20 so that the user or assistant is not exposed to potentialcontaminants. In the embodiment in which a bag 40 is attached to theproximal end 14 (or the funnel 26) of the catheter apparatus 10, the bag40 is subsequently removed and disposed of (or emptied and sanitized).In an embodiment in which a bag 40 is not attached to the proximal end14 or funnel 26 of the catheter apparatus 10, the funnel is directedinto a disposal collection member or waste disposal apparatus, such as atoilet, during evacuation of the bladder.

The conduit 16 may be constructed from a suitable polymeric material,such as polyvinyl chloride (PVC), silicone, latex or other syntheticrubber. The components of the catheter disclosed herein can also be madefrom various well-known materials. For example, the portions of theassembly other than the conduit 16 can be made of polyvinyl propylene,polyvinyl chloride, polyethylene, polypropylene, and other types ofsuitable polymeric materials. The components can be molded or extrudedaccording to well-known manufacturing techniques.

Materials commonly used to make the conduit 16 include, but are notlimited to natural rubber latexes (available, for example, from Guthrie,Inc., Tucson, Ariz.; Firestone, Inc., Akron, Ohio; and Centrotrade USA,Virginia Beach, Va.), silicones (available, for example, from GESilicones, Waterford, N.Y., Wacker Silicones, Adrian, Mich.; and DowCorning, Inc., Midland, Mich.), polyvinyl chlorides (available, forexample, from Kaneka Corp., Inc., New York, N.Y.), polyurethanes(available, for example, from Bayer, Inc., Toronto, Ontario, Rohm & HaasCompany, Philadelphia, Pa.; and Ortec, Inc., Greenville, S.C.),plastisols (available, for example, from G S Industries, Bassett, Va.),polyvinyl acetate, (available, for example from Acetex Corp., Vancouver,British Columbia) polyacrylates (available, for example, from Rohm andHaas, Philadelphia, Pa.) and methacrylate copolymers (available, forexample, from Heveatex, Inc., Fall River, Mass.). Synthetic and naturalrubber latexes, polyurethanes, and silicones are preferred materials.Any combination of the foregoing materials may also be used in makingcatheters such as are used to produce latex Foley catheters.

The urinary catheter of the present disclosure can be manufactured by avariety of well-known methods. The tubing can be extruded and the funnelinjection molded and then cut to the desired length. The tip of the tubecan then be closed and rounded by thermoforming (for example, for PVCtubes) or molded (for example, for silicone tubes). Eye holes can thenbe punched or otherwise formed near the tip of the distal end of thetube to provide an outlet for urine drainage thru the tube when it isinserted into a bladder.

Alternatively, the entire catheter can be fabricated by dip molding. Inthis procedure, an elongated rod or “form” is dipped into a liquidcoating material such as synthetic or natural rubber latex, for example,to form a layer of material on the form. The deposition of material canbe increased by first dipping the form into a coagulant solution to coatthe form with a film of chemical that causes the latex to coagulate ontothe form. Calcium nitrate is commonly used as the coagulant, and otheradditives may be used to enhance the removal of the tube from the formonce the catheter is formed and dried. The form has the shape anddimensions of the lumen of the catheter. The catheter may be formed froma single dip coating of the form or by multiple coating layers. When asuitable material thickness is achieved on a form, the forms are driedto produce the catheter. If multiple coatings are used to form thecatheter, each coating may be dried before the next is applied. Oncedried, the catheter may be stripped from the form. The catheters maythen be washed and dried, and eyelets may then be formed thereon.Further manufacturing steps may be found in U.S. Patent ApplicationPublication No. US 2004/0133156, the disclosure of which is incorporatedby reference herein.

This invention has been described and specific examples of the inventionhave been portrayed. While the invention has been described in terms ofparticular variations and illustrative figures, those of ordinary skillin the art will recognize that the invention is not limited to thevariations or figures described. In addition, where methods and stepsdescribed above indicate certain events occurring in certain order,those of ordinary skill in the art will recognize that the ordering ofcertain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainof the steps may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.Therefore, to the extent there are variations of the invention, whichare within the spirit of the disclosure or equivalent to the inventionsfound in the claims, it is the intent that this patent will cover thosevariations as well. Finally, all publications and patent applicationscited in this specification are herein incorporated by reference intheir entirety as if each individual publication or patent applicationwere specifically and individually put forth herein.

What is claimed is:
 1. A packaged urinary catheter, comprising: aconduit having a proximal end and a distal end, wherein the distal endcomprises at least one aperture for receiving urine from the bladder; asleeve having a length, a width, and a size configured to receive theconduit, wherein the sleeve surrounds substantially the entire length ofthe conduit; and wherein the conduit and the sleeve are arranged in ahelical coil.
 2. The packaged urinary catheter according to claim 1,wherein the shape of the helical coil is maintained by portions of thesleeve being releasably fixed together along at least a portion of thelength of the sleeve.
 3. The packaged urinary catheter according toclaim 1, wherein a first cap is seals a proximal end of the sleeve, anda second cap seals a distal end of the sleeve.
 4. The packaged urinarycatheter according to claim 3, wherein at least one of the first andsecond caps comprises a gripping feature configured to be grasped by apatient or user of the packaged urinary catheter.
 5. The packagedurinary catheter according to claim 4, wherein the gripping feature issized and shaped to receive a finger therethrough.
 6. The packagedurinary catheter according to claim 2, wherein portions of the sleeveare releasably fixed together by a perforated section along a length ofthe sleeve.
 7. The packaged urinary catheter according to claim 3,wherein the packaged urinary catheter is released from the helical coilconfiguration by grasping the first and second caps, and urging the capsin substantially different directions.
 8. The packaged urinary catheteraccording to claim 1, wherein a lubricating material is contained withinthe sleeve.
 9. The packaged urinary catheter according to claim 8,wherein the lubricating material is chosen from water, a hydrogel, and avapor.
 10. The packaged urinary catheter according to claim 1, whereinat least a portion of the outer surface of the conduit is hydrophilic.11. A packaged urinary catheter, comprising: a synthetic polyisopreneconduit having a proximal end and a distal end, wherein the distal endcomprises at least one aperture for receiving urine from the bladder; asleeve having a length, and a width, and a size configured to receivethe conduit, wherein the sleeve surrounds substantially the entirelength of the conduit; and wherein the conduit and the sleeve arearranged in a helical coil.
 12. The packaged urinary catheter accordingto claim 11, wherein the shape of the helical coil is maintained by apackaging material enclosing at least a substantial portion of theconduit and sleeve.
 13. The packaged urinary catheter according to claim11, wherein a first cap seals a proximal end of the sleeve, and a secondcap seals a distal end of the sleeve.
 14. The packaged urinary catheteraccording to claim 13, wherein at least one of the first and second capscomprises a gripping feature configured to be grasped by a patient oruser of the packaged urinary catheter.
 15. The packaged urinary catheteraccording to claim 14, wherein the gripping feature is sized and shapedto receive a finger therethrough.
 16. The packaged urinary catheteraccording to claim 14, wherein the first and second caps are disposedoutside the packaging material.
 17. The packaged urinary catheteraccording to claim 16, wherein the packaged urinary catheter is releasedfrom the helical coil configuration by grasping the first and secondcaps, and urging the caps in substantially different directions.
 18. Thepackaged urinary catheter according to claim 11, wherein a lubricatingmaterial is contained within the sleeve.
 19. The packaged urinarycatheter according to claim 18, wherein the lubricating material ischosen from water, a hydrogel, and a vapor.
 20. The packaged urinarycatheter according to claim 11, wherein at least a portion of the outersurface of the conduit is hydrophilic.